Rapid, topical, local analgesic

Zingo™ is indicated to provide topical, local analgesia to reduce the pain associated with peripheral IV insertions or blood draws, in children three to 18 years of age. Zingo is an easy-to-administer, single-use, needle-free system containing 0.5 mg sterile lidocaine powder. By using compressed gas to accelerate the lidocaine particles into the skin, Zingo provides a rapid onset of action, allowing intravenous line placement or venipuncture to begin one to three minutes after administration.

In two pivotal, randomized, double-blind, placebo-controlled, Phase 3 clinical studies, 1,114 patients across 15 U.S. clinical centers received treatment with Zingo or placebo one to three minutes before blood draws or IV line placements at the back of hand or antecubital fossa (crux of the elbow): Zingo demonstrated a statistically significant reduction in procedural pain compared to placebo in children three to 18 years of age. The most common adverse reactions were redness (erythema), red dots (petechiae) and swelling (edema) at the site of administration.

In clinical trials, the most common adverse reactions (>5%) were skin reactions at the site of administration: redness (erythema), red dots (petechiae) and swelling (edema)2

Results of a randomized, double-blind placebo-controlled Phase 3 clinical trial, enrolling nearly 700 adult patients, demonstrated that patients undergoing peripheral venipuncture or IV cannulation after Zingo treatment experienced significantly less pain versus placebo (p =0.003). The incidence of adverse events was similar to those observed in the pediatric trials, and included redness, red dots and swelling at the site of administration. Anesiva has submitted a supplemental new drug application (sNDA) for the adult Zingo indication and anticipates FDA action by January 2009.

Zingo is marketed in the U.S. for the approved pediatric indication by Anesiva’s hospital-based sales force in tandem with co-promotion partner Sagent Pharmaceuticals, Inc. With a commitment to build Zingo as a global brand, Anesiva has entered into license and distribution agreements currently covering Canada, the majority of Europe, and several countries in the Middle East. Agreements are planned for additional geographic territories.

Zingo Mechanism of Action

Zingo delivers a powder form of lidocaine. Instead of using a needle to deliver the analgesic, Zingo uses compressed gas to accelerate the lidocaine particles into the skin. This provides analgesia in one to three minutes in children.

For more information on Zingo, call 866-ZINGORX (866-946-4679) or send an e-mail to [email protected].

More than 18 million peripheral venous access procedures, including blood draws and IV insertions, are performed on children in U.S. hospitals each year.2 A study published in the journal Pediatric Nursing shows that these types of peripheral venous access procedures are among the most frequently reported painful events in hospitalized children.3

The American Pain Society and the American Academy of Pediatrics, among other organizations, have developed recommendations that emphasize the importance of minimizing procedural pain in children whenever possible.4 However, despite the existence of these recommendations, children undergoing these procedures remain largely under-treated.5 This is partly due to the fact that available local anesthetic creams take 30 minutes to 60 minutes to become effective, making their use in today's fast-paced hospital environment difficult.

American Academy of Pediatrics Committee on Psychosocial Aspects of Child and Family Health and American Pain Society Task Force on Pain in Infants, Children, and Adolescents. The assessment and management of acute pain in infants, children, and adolescents. Pediatrics. 2001;108:793-797.